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TerminatedNCT01558687Updated Feb 4, 2014

Cilengitide Imaging Trial in Glioblastoma

A Phase 1 interventional study of Drug (including placebo) and Standard therapy in Supratentorial Newly Diagnosed Inoperable Gliobastoma, sponsored by Merck KGaA, Darmstadt, Germany. Terminated at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-02-04.

Sponsored by Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Basic science

Why this study was terminated
Discontinuation of development program
Phase
Phase 1
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The main purpose of this clinical trial is to find out if cilengitide has an effect on brain tumor cells but also particularly on the blood vessels supplying the tumor with nutrient and oxygen in patients newly diagnosed with non-resectable (inoperable) glioblastoma.

In addition, this clinical trial will investigate if the addition of cilengitide in combination with standard treatment prolongs life in patients with non-resectable glioblastoma. Similarly, the duration of response of the cancer to this treatment and the side effects of the therapy will be analyzed. Furthermore, additional data on how the body deals with this substance will be collected (this is called pharmacokinetics or pharmacokinetic (PK) analysis). In this clinical trial the investigators would also like to learn more about the disease and the response to the experimental medication by measuring certain "markers".

This imaging trial will investigate the biological effects of cilengitide monotherapy on the tumor microvascular function and tumor viability in a homogenous non-pretreated subject population with newly diagnosed Gliobastoma (GBM). The purpose of this clinical trial is to study the effect that cilengitide may have on certain markers of cancer in your tumor and/or blood and to learn if there are any disease-related markers that could help in predicting how subjects respond to the administration of cilengitide.

The investigators anticipate that approximately 30 subjects will participate in this clinical trial. The clinical trial will be conducted in approximately 4 medical centers in the following countries: Germany, Poland, and Switzerland. The investigators anticipate the clinical trial will last until the end of 2013. Your participation in the trial may last up to 86 weeks.

02

Conditions studied

  • Supratentorial Newly Diagnosed Inoperable Gliobastoma

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Keywords

  • Oncology
  • newly diagnosed inoperable glioblastoma
  • temolozomide
  • radiotherapy
  • dynamic MRI
  • Positron emission tomography
  • [18]FET tracer
  • cilengitide
  • World Health Organization [WHO] Grade IV
03

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 1 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female subject aged ≥ 18 to ≤ 70 years at the time of informed consent signature
  • Tumor tissue specimens taken from multimodal imaging-guided stereotactic biopsy must be available for histopathological confirmation of GBM and potential subsequent analysis of tissue molecular markers
  • Newly diagnosed histologically proven supratentorial GBM (World Health Organization [WHO] Grade IV)
  • Subject with non-resectable GBM
  • Available dynamic MRI and FET-PET scan prior to randomization
  • Available Gd-MRI performed prior randomization
  • ECOG Performance status of 0-2
  • Stable or decreasing dose of steroids for >= 5 days prior to randomization
  • Given written informed consent

Exclusion criteria

Exclusion Criteria:

  • Prior chemotherapy within the last 5 years
  • Prior RTX of the head (except for low-dose radiotherapy for Tinea capitis)
  • Gross total resection/partial resection (GBM surgery), placement of Gliadel® wafer
  • Receiving concurrent investigational agents or receipt of an investigational agent within the past 30 days prior to the first day of intensified imaging (W1D1)
  • Prior systemic antiangiogenic therapy
  • Inability to undergo dynamic MR or FET-PET imaging
  • History of allergic reactions attributed to Gadolinium-based contrast agents for MRI, compounds of similar chemical or biological composition
  • Planned major surgery for other diseases
  • History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months prior to enrollment
  • History of other malignant disease or acute malignant disease. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ≥ 5 years are eligible for this study
  • Current or history of bleeding disorders and/or history of thromboembolic events
  • Clinically manifest myocardial insufficiency (NYHA III, IV) or history of myocardial infarction during the past 6 months prior to enrollment, uncontrolled arterial hypertension
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Group A = Cilengitide Group

    Cilengitide + SoC (Temolozomide + Radiotherapy)

    Drug: Drug (including placebo)

  • Active comparator
    Group B = Control Group

    SoC (Temolozomide + Radiotherapy)

    Other: Standard therapy

Interventions

  • DrugDrug (including placebo)

    Subjects will receive cilengitide monotherapy for 2 weeks (Weeks 1 and 2); thereafter, cilengitide will be given in combination with the standard treatment regimen during Weeks 3 to 36. The standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle. Cilengitide monotherapy treatment will be given to subjects in Group A for another 10 months as maintenance treatment (Weeks 37 to 78). Subjects in Group A may continue to receive cilengitide maintenance treatment beyond 10 months (beyond Week 78) until occurrence of progressive disease (PD) or unacceptable toxicity, or withdrawal for any other reason. A 28-day safety follow-up will be performed after the last dose of cilengitide.

  • OtherStandard therapy

    In the first two weeks, treatment of subjects in Group B will be in line with the SoC. Thereafter the standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.

06

What researchers measure

Primary outcomes

  1. Rate constant for passive contrast agent plasma/interstitium transfer (ktrans)

    Any change in tumor kinetic model parameter (maximum increase in ktrans) to assess the tumor microvasculature structure and function

    Time frame: 2 weeks

  2. Fractional blood plasma volume (vp)

    Any change in tumor kinetic model parameter (maximum change in vp) to assess the tumor microvasculature structure and function

    Time frame: 2 weeks

  3. Maximum tumor to brain ratio (TBRmax)

    Assessment of tumor amino acid (FET) uptake (tumor viability)

    Time frame: 2 weeks

Secondary outcomes

  1. Total tumor volume and enhancing tumor volume

    Change in total tumor volume and enhancing tumor volume as a measure of the overall level of tumor perfusion during the first 2 weeks of treatment with Cilengitide monotherapy

    Time frame: 2 weeks

  2. Interstitial space volume fraction (putative contrast agent distribution volume) (=ve)

    Change in the tumor extravascular extracellular space volume during the first 2 weeks of treatment with Cilengitide monotherapy

    Time frame: 2 weeks

  3. Apparent Diffusion coefficient (ADC)

    Change in perfusion parameter ADC during the first 2 weeks of treatment with Cilengitide monotherapy

    Time frame: 2 weeks

  4. Fractional anisotropy (FA)

    Change in FA during the first 2 weeks of treatment with Cilengitide monotherapy

    Time frame: 2 weeks

  5. Kinetic behavior of [18F]FET uptake

    Change in tumor amino acid (FET) uptake kinetics during the first 2 weeks of treatment with Cilengitide monotherapy

    Time frame: 2 weeks

  6. Mean spin-lattice relaxation time of unbound protons in water

    Change in Absolute T1(mean spin-lattice relaxation time of unbound protons in water) during the first 2 weeks of treatment with Cilengitide monotherapy

    Time frame: 2 weeks

07

Study locations

1 site
  • Merck KGaA Communication Center located in
    Darmstadt, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of Feb 2013 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2012
First posted
Mar 20, 2012
Start
Aug 2012
Primary completionActual
Feb 2013
CompletionActual
Feb 2013
Last update
Feb 4, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01558687
Lead sponsor
Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Mar 20, 2012
Start date
Aug 2012
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Feb 4, 2014

Study contacts

Ute Klinkhardt, MD
study director · Merck KGaA, Darmstadt, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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